Actelion to buy Ceptaris - if FDA backs its cancer treatment

Acquisition contingent on Valchlor approval in rare lymphoma

Actelion is set to acquire US-based biopharma Ceptaris, but only if US regulators approve Ceptaris' cancer treatment Valchlor.

The deal will see Switzerland-based Actelion pay $250m for Ceptaris, as well as further milestones, with Actelion to take full control of its target.

This is all contingent on whether or not the US Food and Drug Administration (FDA) decides to back Valchlor, which is a proprietary gel formulation of mechlorethamine hydrochloride intended for use in the treatment of patients with early-stage mycosis fungoides-type cutaneous T-cell lymphoma.

The disease is a rare type of cancer involving the uncontrolled growth of T cells within the skin for which there are currently no specific drug treatments approved by the FDA.

Ceptaris has already received a knockback from the FDA for Valchlor in May 2012, when the company received a Complete Response Letter explaining the drug could not be approved based on current data.

The company resubmitted a New Drug Application early this year, however, with the FDA also granting the drug orphan status due to the rarity of its proposed indication.

The FDA is now in the late stages of its review process for Valchlor, and a final decision on whether the drug should be granted marketing approval is expected by the end of August 2013.

“Should the FDA approve Valchlor and Actelion acquire Ceptaris, we would be able to offer this meaningfully differentiated medicine to patients who today are dependent on formulations prepared locally by compounding pharmacies in a non-standardised environment,” said Actelion's CEO Dr Jean-Paul Clozel.

“At the same time, we would leverage our existing knowhow and infrastructure in the fields of orphan and ultra-orphan indications when appropriately commercialising Valchlor to specialists in the field of dermatology and oncology."

Valchlor is also under review in Europe where it is also considered an orphan drug.

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